STATUS OF REFORMS TO EPAS

INTEGRATED RISK INFORMATION SYSTEM

JOINT HEARING
BEFORE THE

SUBCOMMITTEE ON OVERSIGHT &

SUBCOMMITTEE ON ENVIRONMENT

COMMITTEE ON SCIENCE, SPACE, AND

TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION

JULY 16, 2014

Serial No. 11386

Printed for the use of the Committee on Science, Space, and Technology

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COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

HON. LAMAR S. SMITH, Texas, Chair
DANA ROHRABACHER, California
EDDIE BERNICE JOHNSON, Texas
RALPH M. HALL, Texas
ZOE LOFGREN, California
F. JAMES SENSENBRENNER, JR.,
DANIEL LIPINSKI, Illinois
Wisconsin
DONNA F. EDWARDS, Maryland
FRANK D. LUCAS, Oklahoma
FREDERICA S. WILSON, Florida
RANDY NEUGEBAUER, Texas
SUZANNE BONAMICI, Oregon
MICHAEL T. MCCAUL, Texas
ERIC SWALWELL, California
PAUL C. BROUN, Georgia
DAN MAFFEI, New York
STEVEN M. PALAZZO, Mississippi
ALAN GRAYSON, Florida
MO BROOKS, Alabama
JOSEPH KENNEDY III, Massachusetts
RANDY HULTGREN, Illinois
SCOTT PETERS, California
LARRY BUCSHON, Indiana
DEREK KILMER, Washington
STEVE STOCKMAN, Texas
AMI BERA, California
BILL POSEY, Florida
ELIZABETH ESTY, Connecticut
CYNTHIA LUMMIS, Wyoming
MARC VEASEY, Texas
DAVID SCHWEIKERT, Arizona
JULIA BROWNLEY, California
THOMAS MASSIE, Kentucky
ROBIN KELLY, Illinois
KEVIN CRAMER, North Dakota
KATHERINE CLARK, Massachusetts
JIM BRIDENSTINE, Oklahoma
RANDY WEBER, Texas
CHRIS COLLINS, New York
BILL JOHNSON, Ohio

SUBCOMMITTEE

ON

OVERSIGHT

HON. PAUL C. BROUN, Georgia, Chair

F. JAMES SENSENBRENNER, JR.,
DAN MAFFEI, New York
Wisconsin
ERIC SWALWELL, California
BILL POSEY, Florida
SCOTT PETERS, California
KEVIN CRAMER, North Dakota
EDDIE BERNICE JOHNSON, Texas
BILL JOHNSON, Ohio
LAMAR S. SMITH, Texas

SUBCOMMITTEE

ON

ENVIRONMENT

HON. DAVID SCHWEIKERT, Arizona, Chair

JIM BRIDENSTINE, Oklahoma
SUZANNE BONAMICI, Oregon
F. JAMES SENSENBRENNER, JR.,
JULIA BROWNLEY, California
Wisconsin
DONNA F. EDWARDS, Maryland
DANA ROHRABACHER, California
ALAN GRAYSON, Florida
RANDY NEUGEBAUER, Texas
KATHERINE CLARK, Massachusetts
PAUL C. BROUN, Georgia
EDDIE BERNICE JOHNSON, Texas
RANDY WEBER, Texas
LAMAR S. SMITH, Texas

(II)

CONTENTS
July 16, 2014
Page

Witness List .............................................................................................................

Hearing Charter ......................................................................................................

2
3

Opening Statements
Statement by Representative Paul C. Broun, Chairman, Subcommittee on
Oversight, Committee on Science, Space, and Technology, U.S. House of
Representatives ....................................................................................................
Written Statement ............................................................................................
Statement by Representative Suzanne Bonamici, Ranking Minority Member,
Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives ...............................................................
Written Statement ............................................................................................
Statement by Representative David Schweikert, Chairman, Subcommittee on
Environment, Committee on Science, Space, and Technology, U.S. House
of Representatives ................................................................................................
Written Statement ............................................................................................

9
10
11
13
14
14

Witnesses:
Dr. David Dorman, Member, Committee to Review EPAs IRIS Process, National Research Council
Oral Statement .................................................................................................
Submitted Biography .......................................................................................
Dr. Kenneth Olden, Director, National Center for Environmental Assessment,
U.S. Environmental Protection Agency
Oral Statement .................................................................................................
Written Statement ............................................................................................
Ms. Rena Steinzor, Professor of Law, University of Maryland; President,
Center for Progressive Reform
Oral Statement .................................................................................................
Written Statement ............................................................................................
Mr. Michael P. Walls, Vice President of Regulatory and Technical Affairs,
American Chemistry Council
Oral Statement .................................................................................................
Written Statement ............................................................................................
Discussion .................................................................................................................

16
18
28
30
39
41
75
77
87

Appendix I: Answers to Post-Hearing Questions

Dr. David Dorman, Member, Committee to Review EPAs IRIS Process, National Research Council .......................................................................................
Dr. Kenneth Olden, Director, National Center for Environmental Assessment,
U.S. Environmental Protection Agency ..............................................................
Ms. Rena Steinzor, Professor of Law, University of Maryland; President,
Center for Progressive Reform ............................................................................
Mr. Michael P. Walls, Vice President of Regulatory and Technical Affairs,
American Chemistry Council ..............................................................................

(III)

96
100
114
123

IV
Page

Appendix II: Additional Material for the Record

Prepared statement by Representative Eddie Bernice Johnson, Ranking Member, Committee on Science, Space, and Technology, U.S. House of Representatives ...........................................................................................................

128

STATUS OF REFORMS TO EPAS

INTEGRATED RISK INFORMATION SYSTEM
WEDNESDAY, JULY 16, 2014

HOUSE OF REPRESENTATIVES,
OVERSIGHT AND SUBCOMMITTEE ON
ENVIRONMENT,
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY,
Washington, D.C.

SUBCOMMITTEE

ON

The Subcommittees met, pursuant to call, at 1:32 p.m., in Room

2318 of the Rayburn House Office Building, Hon. Paul Broun
[Chairman of the Subcommittee on Oversight] presiding.

(1)

9
Chairman BROUN. Good afternoon. This joint hearing of the Subcommittee of Oversight and the Subcommittee on Environment will
come to order. Good afternoon, everyone. We welcome you to todays joint hearing. In front of you are packets containing the written testimony, biographies, and truth in testimony disclosures for
todays witnesses.
Before we get started, since this is a joint hearing involving two
Subcommittees, I want to explain how we will operate procedurally,
so all Members understand how the question and answer period
will be handled. We will recognize those Members present at the
gavel in order of seniority on the Full Committee, and those coming
in after the gavel will be recognized in the order of arrival.
And before I give my opening statement, I want to thankpublicly thank the witnesses, as well as Members, and staff on both
sides for your flexibility. We have a long series of votes that are
going to occur about 2:30, 2:45 this afternoon. We wanted to have
plenty of time for Members, as well as the witnesses, to give their
statements and ask and answer questions, and so I deeply appreciate everyones flexibility in this. Now the Chairman recognizes
himself for five minutes for an opening statement.
Again, I would like to welcome and thank all of our witnesses for
being here today, and for your flexibility in coming in early to accommodate our vote schedule. We dont have control over such matters, so I especially appreciate you all and the Members cooperation.
Over the past decade, this Committee has held many oversight
hearings to examine the EPAs Integrated Risk Information System, or IRIS program. As you all know, IRIS was established three
decades ago to provide a single source of information on the risk
associated with exposure to environmental chemicals for use by
EPA regulatory offices, states, the international community, as well
as industry.
Unfortunately, the program has come under increased scrutiny
as a result of issues related to the pace of assessments, the lack
of transparency, and failure to develop and use consistent approaches to weighing evidence, and characterizing risk in a manner
divorced from actual human exposures.
This scrutiny has come in many forms. Internally, from the EPA
program offices, which have established their own chemical assessments separate from ours, as well as other federal agencies, including the White House, and externally from stakeholder groups that
have increasingly weighed in to express their concern about IRIS
assessments. Even the U.S. Government Accountability Office
placed the program on its high risk series, a list it provides to Congress every two years, for being at high risk for waste, fraud,
abuse, and mismanagement, or in need of broad based transformation.
Congress, and especially this Committee, has shined a spotlight
on the IRIS program for several years, particularly as the National
Research Council has been directed to review some of the more
complex and challenging IRIS assessments. One such example is
the 2011 formaldehyde assessment. When the NRC published their
review, it went beyond its charge to add a very pointed and critical
chapter seven in their report that offered recommendations and

10
suggestions on how EPA could improve the IRIS process. That
eventually led to the NRC report published this May, which identified substantial improvements in the initial stages of EPAs proposed changes to the IRIS program.
That is quite a turnaround from the 2011 report, and I was
pleased to read that, just as I was pleased to read when EPA announced two years ago that it had tapped Dr. Ken Olden to lead
the agencys National Center for Environmental Assessment. Dr.
Olden has been a refreshing ambassador for the IRIS program, and
I applaud his commitment to an open and transparent IRIS process
that includes early communication, and increased opportunities for
meaningful stakeholder input.
But it is clear that the objective of transparency is not a sentiment shared by all. Unfortunately, we have seen opposition to
openness, transparency, and greater public comment from some
corners. Sunshine is the only way to ensure that this reform effort
succeeds, and anti-industry conspiracy theories, and the boycotting
of public meetings do not help the program improve. Dr. Olden and
his staff should be commended for opening up the process to all
stakeholders, and I greatly appreciate your efforts, Dr. Olden, in
that regard.
With that, I am interested in learning more about EPAs timeline
on when it expects to complete its reform process, and, more importantly, when it will publish IRIS assessments that reflect the recommendations and suggestions offered by the NRC to substantially
improve the program.
IRIS will be considered a success when the science behind the assessments is viewed by all stakeholders as rigorous and accurate.
The real metric for progress for IRIS should be the actual content
of the assessments. Are they credible? Do they correctly characterize risk and uncertainty? Can users trust them? Are they overly
conservative in a way that limits the options available to risk managers? If EPA develops such guidelines, handbooks, or policies,
then fails to consistently follow them, we will have spent years,
and millions of taxpayers dollars to reform IRIS on paper.
As a physician, I understand how important it is to ensure the
best possible scientific methods are being utilized to protect our
most sensitive populations, including children, pregnant women,
and the elderly, all from undue harm. Because of this widespread
use, we must be certain that the IRIS program is using the best
possible science, and scientific process, in a timely fashion to publish assessments that engender confidence by all stakeholders.
Anything less than that is a mission not accomplished. Thank you.
[The prepared statement of Mr. Broun follows:]
PREPARED STATEMENT OF SUBCOMMITTEE
CHAIRMAN PAUL BROUN

ON

OVERSIGHT

Good afternoon. I want to welcome and thank all of our witnesses for being here
today.
Over the past decade, this Committee has held many oversight hearings to examine the EPAs Integrated Risk Information System, or IRIS program. As you all
know, IRIS was established three decades ago to provide a single source of information on the risks associated with exposure to environmental chemicals for use by
EPA regulatory offices, states, the international community, and industry. Unfortunately, the program has come under increased scrutiny as a result of issues related

11
to the pace of assessments, lack of transparency, failure to develop and use consistent approaches to weighing evidence, and characterizing risks in a manner divorced from actual human exposures.
This scrutiny has come in many forms: internally, from EPA program officeswho
have established their own chemical assessments separate from IRIS - as well as
other federal agencies, including the White House, and externally, from stakeholder
groups who have increasingly weighed in to express their concerns about IRIS assessments. Even the U.S. Government Accountability Office placed the program on
its High-Risk series, a list it provides to Congress every two years, for being at high
risk for waste, fraud, abuse, and mismanagement or in need of broad-based transformation.
Congress, and especially this Committee, has shined the spotlight on the IRIS
program for several years, particularly as the National Research Council has been
directed to review some of the more complex and challenging IRIS assessments. One
such example is the 2011 formaldehyde assessment. When the NRC published that
review, it went beyond its charge to add a very pointed and critical Chapter Seven
in the report that offered recommendations and suggestions on how EPA could improve the IRIS process. That eventually led to the NRC report published this May,
which identified substantial improvements in the initial stages of EPAs proposed
changes to the IRIS program.
That is quite a turn-around from the 2011 report, and I was pleased to read that,
just as I was pleased when EPA announced two years ago that it had tapped Dr.
Ken Olden to lead the agencys National Center for Environmental Assessment. Dr.
Olden has been a refreshing ambassador for the IRIS program and I applaud his
commitment to an open and transparent IRIS process that includes early communication and increased opportunities for meaningful stakeholder input.
But it is clear that the objective of transparency is not a sentiment shared by all.
Unfortunately, we have seen opposition to openness, transparency, and greater public comment from some corners. Sunshine is the only way to ensure that this reform
effort succeeds, and anti-industry conspiracy theories and the boycotting of public
meetings do not help the program improve. Dr. Olden and his staff should be commended for opening up the process to all stakeholders.
With that, I am interested in learning more about EPAs timeline on when it expects to complete its reform process, and more importantly, when it will publish
IRIS assessments that reflect the recommendations and suggestions offered by the
NRC to substantially improve the program. IRIS will be considered a success when
the science behind the assessments is viewed by all stakeholders as rigorous and
accurate. The real metric for progress for IRIS should be the actual content of the
assessments. Are they credible? Do they correctly characterize risk and uncertainty?
Can users trust them? Are they overly conservative in a way that limits the options
available to risk managers? If EPA develops useful guidelines, handbooks, or policies, then fails to consistently follow them, we will have spent years and millions
of dollars to reform IRIS on paper.
As a physician, I understand how important it is to ensure the best possible scientific methods are being utilized to protect our most sensitive populations, including, children, pregnant women, and the elderly, from undue harm. Because of its
widespread use, we must be certain that the IRIS program is using the best possible
science and scientific process in a timely fashion to publish assessments that engender confidence by all stakeholders. Anything less than that is a mission not accomplished.
Thank you. I now recognize the Ranking Member, the gentleman from New York,
Mr. Maffei, for anopening statement.

Chairman BROUN. And now I recognize the Ranking Member of

the Environment Subcommittee, Ms. Bonamici, for an opening
statement.
Ms. BONAMICI. Thank you very much, Mr. Chairman. And thank
you to our witnesses for testifying before the Subcommittees today.
I want to note that the absence of more Members on this side is
not indicative of our concern about the issue. The change in time
and conflicting hearings are to blame.
So I also want to start by emphasizing, on behalf of my colleagues on my side of the aisle, that we are not anti-industry, nor
are we opposed to the development of new chemicals. We simply
want to ensure that scientific information is available to determine

12
the health effects that might result from exposure. This is about
protecting human health. I am glad you recognize that, Mr. Chairman.
The Integrated Risk Information System, IRIS, was intended to
be a database that would provide a comprehensive source of best
information on the health risks of chemicals. Approximately 700
new chemicals enter the market every year, joining about 85,000
industrial chemicals already in use. Companies that manufacture,
distribute, or use these chemicals are not required to demonstrate
that the chemicals are safe.
When a company wants to introduce a new chemical, the company notifies the EPA, but the company is not required to share
any data regarding the safety of that chemical. EPA cannot even
request safety data unless it can show that there is a potential risk
by pointing to available academic or industry data. It often takes
many years before harms associated with the chemical can begin
to be identified. Thus, there is no good public safety check in place.
There is what seems to be an obvious need for transparency. Despite that, since the 1990s, the industry appears to have used some
strategies to try to slow IRIS entries, tie EPA up in lengthy reviews and inter-agency dialogues, or generally cast doubt on claims
that a particular chemical might have an adverse health effect.
For example, during the Bush Administration, the Office of Management and Budget hired a toxicologist and epidemiologist to run
so-called peer reviews of draft IRIS entries, a policy that resulted
in endless requests from OMB that EPA go back and look at different literature, or make minor changes to their findings. The
Bush Administration also created an inter-agency review process
that allowed agencies with significant pollution problems to challenge the EPA IRIS drafts. Production of new IRIS assessments
was so slow that the GAO put IRIS on their watch listyou mentioned that, Mr. Chairand there was a bipartisan push to let
EPA take control of their program and expand their productivity.
The Obama Administration sought to strengthen IRIS, and
moved OMB into the background while lessening unnecessary
inter-agency review mechanisms. The response from those who are
opposed to IRIS has been to call on the National Research Council
to continually review IRIS assessments. The NRC was drawn into
IRIS several times prior to the 2011 formaldehyde review. In each
case, they largely supported EPAs findings, but offered advice
about how to complete more systematic reviews, and how to improve the science assessments. Invariably, the overall assessments
of EPAs findings were lost in the noise about what the EPA did
not do, or could have done better.
The 2011 report was a little different. The National Research
Council used that report to praise the substantial improvements
thank you, Dr. Oldenmade by the EPA thus far, and offer a road
map how to make IRIS more efficient to accelerate and streamline
the assessments. EPA embraced the advice of the NRC, and, as the
most recent report acknowledges, has made significant progress in
putting into place the process reforms recommended in 2011.
Now we are faced with a question. What is the National Academys off-ramp strategy for getting out of the business of doing endless IRIS reviews? Questions have been raised about whether the

13
American Chemistry Council may have an interest in keeping IRIS
unproductive. Does every NRC report offer an opportunity for criticisms about the quality of the science at the EPA? These are issues
we hope you will address today.
At this point I am very interested to hear whether the Academy
has reached the end of its productive contributions. If not, where
is that point? Frankly, the combination of the 2011 report, the new
leadership at the Center for Environmental Assessment, which has
focused on building a better relationship with industry, has had the
effect of crippling IRIS, rather than putting the EPA on a path to
streamline production of IRIS entries. In fact, unless changes are
implemented, it very well may cripple the program as much as
when OMB was involved, with repeated peer reviews. So I am very
interested to hear from Dr. Olden what you intend to do to get production of IRIS assessments moving.
I look forward to the testimony from each of the witnesses. There
have been a lot of questions raised, but, importantly, this Committee needs to hear how we are going to get out of the way, let
EPA do its job of producing assessments of chemicals that may be
suspected of, and may be causing harm to our constituents and our
communities. Thank you very much, Mr. Chairman, and I yield
back.
[The prepared statement of Ms. Bonamici follows:]
PREPARED STATEMENT OF SUBCOMMITTEE ON ENVIRONMENT
RANKING MINORITY MEMBER SUZANNE BONAMICI
Thank you, Mr. Chairman, and thank you to our witnesses for testifying before
our Subcommittees today. I want to start by emphasizing on behalf of my side of
the aisle that we are not anti-chemical or opposed to the development of new chemicalswe simply want to assure that scientific information is available to determine
the health effects that might result from exposure. This is about protecting human
health.
The Integrated Risk Information System, IRIS, was intended to be a database
that would provide a comprehensive source of best information on the health risks
of chemicals. Approximately seven hundred new chemicals enter the market every
year, joining about 85,000 industrial chemicals already in use. Companies that manufacture, distribute, or use these chemicals are not required to demonstrate that the
chemicals are safe.
When a company wants to introduce a new chemical, the company notifies the
EPA, but the company is not required to share any data regarding the safety of that
chemical. EPA cannot even request safety data unless it can show there is a potential risk by pointing to available academic or industry data. It often takes many
years before harms associated with a chemical can begin to be identified, thus there
is no good public safety check in place.
There is what seems to be an obvious need for transparency. Despite that, since
the 1990s the chemical industry appears to have used strategies to try to slow IRIS
entries, tie EPA up in lengthy reviews and interagency dialogues, and generally cast
doubt on claims that a particular chemical might have an adverse health effect. For
example, during the Bush Administration, the Office of Management and Budget
hired a toxicologist and an epidemiologist to run so-called peer reviews of draft
IRIS entries, a policy that resulted in endless requests from OMB that EPA go back
and look at different literature or make minor changes to their findings. The Bush
Administration also created an interagency review process that allowed agencies
with significant pollution problems to challenge the EPA IRIS drafts. Production of
new IRIS assessments was so slow that GAO put IRIS on their watch list, and
there was a bipartisan push to let EPA take control of their program and expand
their productivity.
The Obama Administration sought to strengthen IRIS, and moved OMB into the
background while lessening unnecessary interagency review mechanisms. The response from those who are opposed to IRISs work has been to call on the National

14
Research Council to continually review IRIS assessments. The NRC was drawn into
IRIS several times prior to the 2011 Formaldehyde review. In each case they largely
supported EPAs findings, but offered advice about how to complete more systematic
reviews and how to improve the science assessments. Invariably, the overall endorsements of EPAs findings were lost in the noise about what EPA did not do or
could have done better.
The 2011 report was a little different. The National Research Council (NRC) used
that report to praise the substantial improvements made by EPA thus far, and offer
a road map for how to make IRIS more efficient, and to accelerate and streamline
the assessments. EPA embraced the advice of the NRC and, as the most recent report acknowledges, has made significant progress in putting into place the process
reforms recommended in 2011. Now we are faced with a necessary question: what
is the National Academys off-ramp strategy for getting out of the business of doing
endless IRIS reviews? Organizations such as the American Chemistry Council may
have an interest in keeping IRIS unproductive, and discrediting its work could keep
the Academy busy as every NRC report offers an opportunity for criticisms about
the quality of the science at EPA. At this point, I am very interested to hear whether the Academy has reached the end of its productive contributions. If they have
not reached that point, where might that point be?
Frankly the combination of the 2011 report and the new leadership at the National Center for Environmental Assessment, which has focused on building a better
relationship with industry, has had the effect of crippling IRIS rather than putting
the EPA on a path to streamlined production of IRIS entries. In fact, unless changes
are implemented, it may very well cripple the program as much as when OMB was
involved with repeated peer reviews. So I am very interested to hear from Dr.
Olden about what he intends to do to get production of IRIS assessments moving.
I look forward to the testimony from each of the witnesses. But importantly, this
Committee needs to hear how we are going to get out of the way and let EPA do
its job of producing assessments of chemicals that are suspected of and may be causing harm to our constituents and our communities.

Chairman BROUN. Thank you, Ms. Bonamici. Now the Chair recognizes the Chairman of the Subcommittee on Environment, the
gentleman from Arizona, Mr. Schweikert, for his opening statement. You are recognized for five minutes.
Mr. SCHWEIKERT. Thank you, Mr. Chairman. We will do this
quickly, to be economical with time, because of the votes coming
up. Welcome to the chaos of this time of year.
I have three quick things. One, I need to say goodbye to Mr.
Woods here, though his unwillingness to shave demonstrates he
knows he is leaving us this coming week. Number two, something
that almost has never happened in my couple years around here,
I talked to some folks who care very much about what is done here,
and they actually said nice things about you, Dr. Olden. You have
no idea how rare it is to hear nice things about anyone around
here.
And, number three, one of the comments that came up, both from
some folks I met who you consider on the left and the right, is the
encouragement and the hope that the continued movement to be
more transparent with data, so folks can review and understand,
continues. There was a great warmth from both sides that was
heading in the right direction. With that, Mr. Chairman, I yield
back.
[The prepared statement of Mr. Schweikert follows:]
PREPARED STATEMENT OF ENVIRONMENT SUBCOMMITTEE
CHAIRMAN DAVID SCHWEIKERT
EPAs Integrated Risk Information System, or IRIS, is designed to provide quantitative and non-quantitative toxicity information for a suite of chemicals. The purpose of this program is to provide basic scientific determinations about what is a
safe level and to be used by both EPA program offices and States.

15
This program has never been authorized by Congress and, over the last decade,
has been strongly criticized by the National Academy of Sciences, the Government
Accountability Office (it was listed as a High risk program in 2009 and remains
on the list), the environmental community, industry, and both parties.
The National Research Council rightly found that critical reforms that promote
greater openness, transparency, and stakeholder engagement are currently underway by EPA, led by Dr. Ken Olden.
It is important to note that these limited reforms are simply a work in progress
not a single complete assessment has benefited from this new framework. The NRC
report was a snapshot in time, and even these limited reforms have been criticized
in some corners.
Specifically, the NRC called on EPA to:
Increase the transparency of how IRIS assessments are conducted and of the
criteria EPA uses;
Adopt better methodologies for systematic review of the literature, for evaluating evidence, and for integrating evidence across different types of scientific
information;
Rely on more high quality studies;
Conduct better peer review;
Increase the role of outside experts; and
Better manage the program to improve its efficiency and to stay current with
scientific advances.
Most of these reforms have focused on process, but there are key areas in the content of these assessments that limit their credibility. States, industry, and the public do not trust the IRIS assessments.
The former Science Advisor for EPA recently wrote in Nature that: Fundamentally, the EPA should replace risk values that are built on science-policy assumptions with risk estimates that acknowledge underlying uncertainties. The EPAs definitive values are illusions; they conceal uncertainty that cannot be resolved scientifically.

Chairman BROUN. Well, that was quick. Thank you, Mr.

Schweikert. If there are Members who wish to submit additional
opening comments or statements, your statements will be added to
the record at this point.
Chairman BROUN. At this time I would like to introduce our
panel of witnesses. Our first witness is Dr. David Dorman, member
of the National Research Councils Committee to Review the EPAs
IRIS Process.
Our second witness, and star, is Dr. Ken Olden, Director of the
National Center for Environmental Assessment at the U.S. Environmental Protection Agency. And, I just want to reiterate what
Mr. Schweikert said. It is just so nice to have good comments, and
it is rare around here, Dr. Olden.
Our third witness is Ms. Rena Steinzor, Professor of Law at the
University of Maryland, and President of the Center for Progressive Reform. Glad to have you, as well as our final witness, Mr. Michael Walls, Vice President of Regulatory and Technical Affairs at
the American Chemistry Council.
Now, as the witnesses should know, spoken testimony is limited
to five minutes each, and if you would please try to limit your comments to five minutes. I am not going to gavel you down, but we
do have votes forthcoming fairly quickly. So if you would, please try
to limit your comments to five minutes, after which Members of the
committee will have five minutes each to ask questions.
It is the practice of the Subcommittee on Oversight to receive
testimony under oath. If you would all please stand. Raise your
right hand. Do you solemnly swear to affirm to tell the whole truth,
and nothing but the truth, so help you God? Dr. Dorman? Okay,

16
very good. You may be seated. Let the record reflect that the witnesses participating have all taken the oath.
I now recognize Dr. Dorman for five minutes.
TESTIMONY OF DR. DAVID DORMAN,
MEMBER, COMMITTEE TO REVIEW EPAS IRIS PROCESS,
NATIONAL RESEARCH COUNCIL

Dr. DORMAN. Okay. Good afternoon, Dr. Broun, Chairman

Schweikert, Ranking Member Bonamici, and other Members of the
Subcommittees. My name is David Dorman. I am a professor of
toxicology at North Carolina State University, and I served as a
member of the National Research Council Committees to review
the IRIS process, and the NRC Committee to review EPAs draft
IRIS assessment of Formaldehyde. I am pleased to appear before
you today to discuss aspects of the report, Review of EPAs Integrated Risk Information System Process, which was released earlier this year, in May of 2014.
This report, which I have a copy of, andwas written by a 15
member committee of the National Research Council of the National Academies. The committee was asked to assess the scientific,
technical, and process changes being implemented or planned by
EPA, and to recommend modifications, or additional changes, as
appropriate, to try to improve the scientific and technical performance of the IRIS process. Recommendations in the earlier NRC
formaldehyde report, as mentioned earlier, provided the impetus
for the changes to EPAs IRIS program.
Overall, the IRIS committee found that the changes that EPA
has proposed and implemented to various degrees constitute substantial improvements in the IRIS process. If current trajectories
are maintained, some of the inconsistencies identified in our report
are addressed, and planned revisions still to be implemented are
successfully completed, the IRIS process will become much more effective and efficient in achieving the programs basic goal of developing assessments that provide an evidence-based foundation for
ensuring that chemical hazards are optimally addressed, and assessed through a transparent and replicable approach.
The IRIS committee reviewed and evaluated the overall process,
and each individual step of the process, and the changes that EPA
has made, or is planning to make, and offered recommendations.
Additionally, the IRIS committee identified three broad areas on
which the EPA should focus attention.
First, EPAs assessment methods will need to be updated in a
continuing strategic process, and EPA should develop a plan for
doing so. Second, the sources of inefficiencies in the IRIS process
need to be identified and addressed systematically. Third, EPA
management needs to evaluate human and technologic resources
that are needed to conduct IRIS assessments, and support
methodologic research, and the implementation of new approaches.
The IRIS committee emphasized that if sufficient financial and
staff resources are not available to EPA, then it will not be able
to continue to improve the IRIS program, and keep pace with scientific advancement.
As noted, the IRIS committee found that substantial improvements in the IRIS process have been made, and it is clear that

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EPA has embraced, and is acting on the recommendations in the
NRC formaldehyde report. The NRC formaldehyde committee recognized that these suggested changes would take several years,
and an extensive effort on the part of EPA staff to implement. Substantial progress, however, has been made in a short time, and the
IRIS committees recommendation should be seen as building on
the progress that EPA has already made.
Thank you for the opportunity to testify, and I would be happy
to answer any questions that the Committee would like me to address. Thank you.
[The prepared statement of Dr. Dorman follows:]

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Chairman BROUN. Thank you, Dr. Dorman. The Chair now recognizes Dr. Olden for five minutes.
TESTIMONY OF DR. KENNETH OLDEN, DIRECTOR,
NATIONAL CENTER FOR ENVIRONMENTAL ASSESSMENT,
U.S. ENVIRONMENTAL PROTECTION AGENCY

Dr. OLDEN. Good afternoon, Chairman Broun, Ranking Member

Maffei, Chairman Schweikert, and Ranking Member Bonamici, and
distinguished Members of the Committee. My name is Kenneth
Olden, and I am the director of the National Center for Environmental Assessment, in the Office of Research and Development in
the U.S. Environmental Protection Agency. We appreciate your interest in the Integrated Risk Information System, commonly called
IRIS. Today I am pleased to report that the changes that we have
made in the program over the past two years have been welcomed,
and well received.
A May 2014 report by the National Academies National Research
Council commended our progress, and recognized that we have
made a tremendous amount of progress in a short time. Yes, we
are pleased that the NRC committee recognized the progress that
we have made. However, it is not time to celebrate, or to declare
victory. In fact, we are humbled by the work that remains to be
done.
Our vision is to complete the transformation of IRIS into a highly
effective world class scientific enterprise. To achieve this objective,
the IRIS program has embraced the use of the best science and informational technologies available to estimate the risk from chemical exposures. Furthermore, we have instituted several structural
and programmatic changes to ensure transparency, objectivity, and
scientific rigor in the assessment process.
In the interest of time, I will highlight three in my oral testimony today. First, we incorporated principles of systematic structured review methodologies to identify, to evaluate, and to integrate data from the three different evidence streams that we use
in toxicityin estimation of toxicity values. These approaches
make use of explicit pre-specified rules to select, to evaluate, and
to synthesize data relevant to the specific chemical assessment.
Such approaches give results that are highly reproducible, and
eliminate bias associated with expert judgment.
However, I might add that methodologies used in systematic review and evidence integration were developed for the use of evidence medicine. In such cases, one is comparing effectiveness of
Drug A versus Drug B in a chemical trial. In the case of IRIS assessments, we are integrating evidence from three streams, epidemiology, animal studies, and mode of action, or mechanistic studies.
Except for the Bradford-Hill guidelines used in cancer hazard assessment, the effectiveness and potential for risk of bias for integration of evidence from such diverse sources using these methodologies have not been evaluated. While useful in evidence-based
medicine, these methodologies may need to be customized for IRIS
purposes. However, I caution that we do not want to make the
structured process so rigid as to exclude expert judgment. In the

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end, we may end up with a process that combines expert judgment
with some sort of structured approach.
Second, we instituted activities to proactively engage the public
during critical stages of the assessment process. For example, we
hold bimonthly IRIS public meetings to discuss scientific issues related to preliminary assessment materials and draft IRIS assessments. These meetings provide opportunity for public input on the
literature identified, and evidence tables that we have prepared for
use in the assessment. For example, have we failed to identify all
the studies pertinent to the assessment? Have we identified the
right disease endpoints likely to be caused by the specific chemical
exposure?
And finally, to improve quality and consistency of peer review,
we have created a standing chemical assessment advisory committee under the auspices of EPAs Scientific Advisory Board to
conduct peer review of IRIS assessments. Since we will have regular and frequent interactions with this committee, systemic and
recurring problems can be defined and eliminated, and consensus
opinions of the committee will provide quality assurance, and will
lend credibility to the assessments. Moreover, impetus to be responsive to the peer review recommendations will be much higher.
However, it is my job to ensure the quality and integrity of IRIS
assessments.
And, in summary, the transformation of IRIS is well underway.
As the individual with primary responsibility for the IRIS program,
I can assure you that the EPA fully intends to successfully complete the transformation. The recommendations made by the NRC
committees are absolutely consistent with our commitment to
transparency and scientific excellence. While we are fully cognizant
of the urgency to completely implement the NRC recommendations,
our number one priority is to get the science and the process right.
Thank you, and I would be pleased to respond to any questions
that you might have.
[The prepared statement of Dr. Olden follows:]

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Chairman BROUN. Thank you, Dr. Olden. Ms. Steinzor, you are
recognized for five minutes.
TESTIMONY OF MS. RENA STEINZOR,
PROFESSOR OF LAW, UNIVERSITY OF MARYLAND;
RESIDENT, CENTER FOR PROGRESSIVE REFORM

Ms. STEINZOR. Thank you for the opportunity to testify this afternoon about how to get EPAs IRIS program back on track. IRIS assessments are invaluable because they are robust and well documented, are summarized clearly and concisely, and are available to
anyone who has access to the Internet. Individuals, community
groups, public interest organizations, government officials, in short,
everyone, not just in this country, but around the world, can get
information they need to make well informed decisions about toxic
hazards. Conversely, delaying the production of IRIS profiles
causes real and devastating harm to public health. It also saves the
chemical industry lots of money.
My testimony today makes three points. First, IRIS assessments
have once again slowed to a crawl, sinking to the depths of the
poor performance achieved under the Bush Administration. The
Obama Administration needs to stop jawboning with industry
stakeholders, and concentrate on revitalizing this vital initiative.
The highest best use of the National Academys expertise would
be to help the IRIS program identify ways to develop a significantly
larger number of robust assessments quickly, on a limited budget.
Congress, the EPA administrator, and the National Academies
must confront the very serious problem of regulated industrys commandeering the IRIS assessment process by barraging the agency
with endless minor repetitive and irrelevant objections to risk assessments.
Unfortunately, although its potential is great, IRISs promise is
compromised by disturbing data gaps. As GAO has reported, IRIS
is rapidly becoming one of EPAs walking dead programs. The
agencys efforts to fill IRISs data gaps were largely stymied during
the Bush Administration, and not by accident. That administration
imposed reforms designed to subject EPAs scientists to a host of
political pressures from government agencies with neither scientific
expertise, nor an interest in protecting public health and the environment.
The Obama Administration recognized the problem, but its revisions to the IRIS process left key issues unaddressed. Of late, the
administration has displayed a disturbing tendency to retreat in
the face of a blistering and self-serving industry campaign to stifle
this vital program once and for all.
The two National Academies committees responsible for reviewing IRIS have missed golden opportunities to provide constructive
advice on how to develop new assessments quickly. Rather than
flyspecking the faults of specific IRIS assessments, and subjecting
the program as a whole to a round robin of highly critical examination, three issues must be addressed to solve this problem, revamping the IRIS programs agenda, adopting so-called stopping rules,
and ending duplicative rounds of stakeholder consultations dominated by regulated industries.

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Once EPA starts an IRIS assessment, there must be an end in
sight, an assessment must be declared finished, and its results
posted on the web. When significant new science is produced suggesting that the numbers must be lowered or raised, EPA can reexamine the profile. But as exemplified by the chromium compound
assessment, regulated industries often manage to push EPA onto
a treadmill, where it never escapes the wait for another study. The
trouble, of course, is that science is always evolving. EPA cannot
wait on all the science to resolve itself, and the truth to be announced. That simply is not the nature of the scientific enterprise.
The final problem is the decision by EPA political appointees to
deal with the attacks on IRIS by hosting numerous stakeholder engagement events, some tied to specific assessments, others related
to broader science issues, or even general concerns about the program as a whole. EPAs political appointees seem to harbor the
nave idea that this process will placate its critics. Instead, endless
jawboning has left the agency vulnerable to cynical exploitation.
In sum, let us not lose sight of what is really at stake, the priceless notion that the water we drink and the air we breathe ought
to be clean and healthy. Thank you.
[The prepared statement of Ms. Steinzor follows:]

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Chairman BROUN. Thank you, Ms. Steinzor. Mr. Walls, you are
recognized for five minutes.
TESTIMONY OF MR. MICHAEL P. WALLS,
VICE PRESIDENT OF REGULATORY AND TECHNICAL AFFAIRS,
AMERICAN CHEMISTRY COUNCIL

Mr. WALLS. Good afternoon, Dr. Broun, Ranking Member

Bonamici, Chairman Schweikert, and the Members of the Committee. We very much appreciate the opportunity to appear here
today to comment on progress in the IRIS program.
You can count me among the fans of Ken Olden. We would like
to compliment Ken for his leadership in the IRIS program. The
changes he has instituted since the NAS report in 2011 isare
bringing IRIS closer to a high standard of public engagement,
transparency, and openness. We share his interest, and the programs interest, in assuring that IRIS assessments can help EPA
and others do a better job of protecting health and the environment.
We are concerned, however, that some of the policies and practices in the program continue to perpetuate the development of unrealistic overestimates of risk. These shortcomings can have real,
if unintended, consequences. And that is because the risk management decisions that are made by federal and state governments, for
example, routinely draw upon the numbers generated in assessment programs like the IRIS program.
Now, ACC recently released a set of principles that set out attainable high level benchmarks for federal assessment programs.
Our principles focus on four areas, improvement in assessment design, improvement in data and method integration and review, how
those assessments are communicated, and review and accountability in those programs. Our principles are consistent not only
with the NAS reports, but are consistent as well with the administrations own science integrity goals.
At this point in time, however, and I think as Dr. Olden has
noted, much work remains to be done to ensure those benchmarks
are achieved in the program. The 2011 report identified significant
scientific shortcomings in the program. EPA, to its credit, is committed to fully implementing those recommendations.
But now, three years after the 2011 report was released, many
of the most critical changes remain to be fully implemented. In
fact, materials released by the agency just last weekin those materials released just last week, EPA indicated that only two of the
chemicals now in the IRIS pipeline even have any chance of being
fully consistent with the 2011 recommendations, as well as the enhancements that Dr. Olden himself has implemented. The NASs
2014 report acknowledged that progress has been made. It also reiterated several of the same concerns noted in 2011, and made further recommendations for improvement.
Now, in our view, the most critical area for IRIS reform is evaluating and integrating scientific evidence in a transparent and robust manner. For example, IRIS has identified study quality considerations for certain scientific evidence, but the assessments have
not systematically and transparently evaluated the studies against

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those considerations. NAS recommended that in 2011, and did so
again in 2014.
IRIS assessments needs to consistently address mode of action.
That is how the human body works, and the way the chemicals
interact with the body at different levels of exposure. But EPAs
approach, however, has left stakeholders guessing about how mode
of action and mechanistic information will be used. If IRIS assessments are designed well from the very beginning, the agency can
organize the available information to evaluate the plausible alternative hypotheses, and they can do so in a much more timely way.
They will be much more productive at getting assessments completed. We think EPA should also articulate a better standard for
using data, instead of default assumptions, as well as more effectively addressing peer review.
Finally, how the agency characterizes and communicates this information to the public is critically important. When assumptions
are used in lieu of data, the assumptions should be disclosed, along
with the justification for their use. The NAS this year called on the
EPA to develop guidelines for uncertainty analysis and communication. The IRIS assessments themselves should provide a complete
picture of what is known and what is inferred.
But just this past Monday, at a meeting of the chemical assessment advisory committee, in their review of the ammonia assessment, it demonstrated that the panel itself couldnt figure out why
EPAhow EPA chose some numbers, and why they did that. So we
are looking forward to continuing our work with your Committee,
with Dr. Olden, and other stakeholders to make sure that the NAS
recommendations, as well as the principles we have articulated are
implemented in the program.
We hope, in fact, that other EPA program offices, and other federal agencies, will carefully consider the recommendations by the
NAS to make appropriate improvements in their own programs.
We share a mutual interest in ensuring that high quality information is applied to make better, more timely public health decisions.
Thank you.
[The prepared statement of Mr. Walls follows:]

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Chairman BROUN. Thank you, Mr. Walls. We have been informed
that we are going to start having votes at about 2:10, about a
minute or a minute and a half from now, and it is going to be long
series. So, to try to expedite things, and get to as many Members
as we possibly can, the minority and I have agreed that we are
going to limit each Member to three minutes so that we can try to
get through as many Members as possible. We will offer you all the
opportunity to answer questions, and their questions for the record,
QFRs, as we normally call them, so please be expeditious in giving
those back to us. Thank you all for your testimony. I will open the
first round of questions now, and I recognize myself for three minutes.
Dr. Olden, as I mentioned in my statement, I appreciate all of
your efforts to reform the IRIS program, including your attempts
to increase transparency and stakeholder input. I do wonder, however, when will this process be completed, and when will the EPA
publish its first IRIS assessment that will reflect all of the recommendations and suggestions offered by NRC to substantially improve the program?
And then, furthermore, do you anticipate the first couple of IRIS
assessments that will incorporate all of the NRC recommendations
to be on new chemicals, and if so, which ones will be first, or will
there be updates of old assessments, and if so, which ones?
Dr. OLDEN. Chairman Broun, any chemical that was started
after the 2011 formaldehyde report will have all the recommendations that were included in the formaldehyde NRC committee report. So how many chemicals that is, I am not absolutely certain.
But I would say byin three to five years we will have completely
implemented all the recommendations of the NRC reports.
Chairman BROUN. Are you talking about three to five years from
now, or when you began the process?
Dr. OLDEN. three to five years from now.
Chairman BROUN. Okay.
Dr. OLDEN. Right.
Chairman BROUN. Are new chemicals involved in the assessment, or are you just going to do old ones? And which ones are you
going to test?
Dr. OLDEN. There are new chemicals in the pipeline that will be
involved in the assessment. And there are probably some old ones.
I can get back to you with the specifics. But there will be both new,
and possibly some old chemicals.
Chairman BROUN. Okay.
Chairman BROUN. Can you give us a number?
Dr. OLDEN. What we are doing now is doing a strategiclong
term strategic planning to identify the needs of the agency. And
once we getso we send a survey out to all the program directors
and regional directors, and we are getting that information back.
When we assemble that information, we will makeknow which
chemicals the agency needs, and we will make assessment of those
chemicals our highest priority.
Chairman BROUN. Thank you, Dr. Olden. Ms. Bonamici, you are
recognized for three minutes.
Ms. BONAMICI. Thank you very much, Mr. Chairman.

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Ms. Steinzor, you mentioned in your testimony some of the
health effects of chemicals for which IRIS has provided scientific
documentation, for exampleor scientific determinations, excuse
me, brain damage, cardiovascular illness, reproductive dysfunction,
cancer. That is a list that should cause us to pay attention, and I
want to bring up something that you mentioned in your written
testimony, the January 2014 chemical spill in West Virginia. As
you indicated in your testimony at the time of the spill, the chemical being used, called Crude MCHM, was not in the IRIS database.
So, briefly, and then I will ask you to expand in writing, under
the current IRIS and EPA process, what would have to happen before a chemical like MCHM would be subject to an IRIS assessment?
Ms. STEINZOR. Well, the problem with that chemical is it is not
listed in any of the statutes, such as the Clean Air Act or the Safe
Drinking Water Act, as being a contaminant of concern, and yet we
saw that it caused very grave problems in West Virginia. For it to
make its way onto the IRIS list, and actually have an assessment
completed, our calculations are it would take decades at the rate
they are going, and that is very unfortunate.
As you know, the people there have been told that they need to
make a personal decision about whether to shower, or bathe their
babies in the water.
Ms. BONAMICI. And I am going to try to get a couple more questions in. Now, recently this Committee took up a bill alleging secret
science at the EPA. We hear a lot about the need for transparency.
Now, it is my understanding that the companies do not have to
demonstrate the safety of their products. And, in fact, safety data
is often treated as proprietary. So we all know that we need chemicals for modern society, but how can we be confident that the
chemicals in the marketplace are not harming us?
Ms. STEINZOR. I dont think we can be confident, as the West Virginia example shows, and I would urge you to take a very careful
look at that bill. That bill would make it even more difficult for
EPA to assess chemicals by raising the burden of what kind of evidence they have to have, in lieu of a testing requirement, very
high.
Mr. WALLS. Ms. Bonamici, may I make a comment quickly on
that?
Ms. BONAMICI. Well, I only have 41 seconds. For the record,
please do submit.
Dr. Dorman, thank you for the Academyfor all your work that
you have done. Can you tell me when the Academys work will be
completed, and at what point will you be finished with changing
the process, or contributing to the process?
Dr. DORMAN. So with respect to the report that was issued in
May, I mean, that is a project that has been completed. One of the
things to keep in mind is that the Academys activities, having
been a member of several committees now, have largely been directed by either Congress, mandated by Congress, or else requested
by EPA. And so, really, a lot of the work that the Academies is
doing with respect to the IRIS program is being driven by those
factors.

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Ms. BONAMICI. And do you still have productive contributions to
make?
Dr. DORMAN. So right now to my knowledge, the Academiesthe
only IRIS processone that we are looking at right now, or the
Academies is looking at, is related to arsenic.
Ms. BONAMICI. Thank you. I am out of time, and, Dr. Olden, I
will be submitting more questions for the record. I yield back
Chairman BROUN. Thank you, Ms. Bonamici.
Chairman Schweikert, you are recognized for three minutes.
Mr. SCHWEIKERT. Thank you, Mr. Chairman. It feels sort of like
the lightning round. As Ms. Bonamici touched on, one of the benefits, obviously, of the Secret Science Bill is if EPA uses industry
data, it has to become public. The baseline data sets become public.
So I am hoping that actually sort of provides a benefit for everyone.
Mr. Dorman, I have one concern, and let us see if I can articulate
this quickly. A standard parts per million is created in this process.
Dont we have OSHA, CDC, even other parts of EPA, and then on
occasion I will see European standards, as well as others. Are we
in a world right now where we have lots and lots of different
benchmarks being offered? Is there a need to start trying to do a
consolidation of what is the standard of health attributes? And
thenfirst that one, then there is an auxiliary to that.
Dr. DORMAN. So you raise a great point. There are a number of
different agencies charged by individual companies, or countries, to
try to come up with different types of exposure standards, for example, Health Canada versus EPA, and sometimes there are divergent numbers that are developed both within the United States
and elsewhere. A lot of that depends upon what the populations at
risk sometimes represent. So, for example, if OSHA is creating a
standard for workers, that standard may be very different than
what EPA is required to do for the general population.
But the methodologiesI think one of the things that our committee was stressing is that in any case, what EPAwhen they are
developing those numbers, try to be as transparent as possible so
people can look at how those numbers were actually developed.
Mr. SCHWEIKERT. Okay. Mr. Dorman, so, if we knew all these different regulators that are publishing data on different chemicals
are following a standardized methodology for analysis
Dr. DORMAN. Right.
Mr. SCHWEIKERT., then there is the next part of that. Instead
of saying, here is my benchmark, it is blank parts per million,
shouldnt it be blank parts per million when handled in this fashion? In this fashion, you might have other types of mitigation. Are
we also doing a good enough job providing those other levels a definition of it also has to do with environment, being used in industry,
mechanics, the other attributes around it?
Dr. DORMAN. Right. So, very quickly, again, it comes back to
for example, on the OSHA numbers, those oftentimes will look at
personal protection, which wasnot be available to the general
population, which EPA is now viewing for, say, the RFC or RFD
values. So these numbers that EPA is developing are for unprotected populations at risk.
Mr. SCHWEIKERT. Okay. And, Mr. Chairman, I promise all of you
I will have some questions in writing. I have a sort of a fixation

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on data, whether you think it helps you or hurts you, becoming
public, because I think we need to also trust the kids at a university, a left wing group, a right wing group, from being able to have
opportunities to analyze data, and compare with other data sets.
With that, I yield back, Mr. Chairman.
Chairman BROUN. Thank you, Mr. Schweikert. Ms. Clark, you
are recognized for three minutes.
Ms. CLARK. Thank you, Mr. Chairman.
Dr. Dorman, when Dr. Samet testified before this Committee on
the 2011 formaldehyde report, he made it very clear that the NAS
panel was not calling for the EPA to suspend IRIS assessments,
and was not saying that they could not do quality, solid assessments. Instead, was recommending reforms in the process that
could be implemented in parallel with continuing IRIS assessments. Can you tell me, is that still the position of the NAS panel?
Dr. DORMAN. So I think that Dr. Samets comments were echoed
in our recent IRIS report, and
Ms. CLARK. Um-hum.
Dr. DORMAN. the bottom line is that for EPA, when the Committee was trying to look at the changes that EPA was making,
those were in progress. And so what we felt as a committee, and
felt strongly, was that implementation of different attributes within the process may take different periods of time in order to fully
implement. And so we recognize that, both in the formaldehyde report that I served on, as well as the IRIS committee.
And so I think the bottom line was neither committee had the
anticipation that we would see full cloth changes, but rather we
were seeing a progress that was occurring, that we could then
judge to see where they were going.
Ms. CLARK. And in both the new report, and in your testimony,
it was found there were substantial improvement in EPAs process,
in line with those recommendations from 2011. Do you see any evidence that EPA is producing what some have called flawed assessments?
Dr. DORMAN. So I think it is important that we were charged
with looking at the process, rather than any individual assessments, per se. So we werent asked to do any independent assessments, or reviews of assessments, but what we did see was a pattern on the part of EPA in which they were very proactively implementing the changes in the formaldehyde. And what we see is,
once these are all fully implemented, we believe that the quality
of the assessments will actually improve dramatically.
Ms. CLARK. Thank you.
Mr. Walls, in your testimony you talkedreferred a few times to
timely manner of these assessments. Do you believe the IRIS program is completing assessments in a timely manner?
Mr. WALLS. Congresswoman Clark, I think our view would be
that IRIS can do a better job, and, if it systemically implements the
recommendations made by the NAS, for example, can get to a
steady state stage, where they can regularly and confidently
produce these assessments.
Ms. CLARK. Would the industry support additional resources to
make this happen for IRIS?

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Mr. WALLS. We have made clear our support for the agency having appropriate resources to do this work.
Ms. CLARK. Thank you.
Chairman BROUN. Thank you, Ms. Clark.
Mr. Swalwell, you are recognized for three minutes. And please
be quick, because I would like to get to Ms. Edwards, if we can,
beforeand give her a chance too. So you are recognized for
Mr. SWALWELL. I will, and I have just one question for Professor
Steinzor, and I am a former University of Maryland School of Law
student, so I am thrilled
Ms. STEINZOR. Fantastic.
Mr. SWALWELL. you are there. Professor Steinzor, you acknowledged in your testimony that the science of risk is always evolving,
yet the Academies have suggested, in their recent report, that EPA
adopt firm stopping rules for key points in the IRIS process. Although it may appear obvious to most, could you elaborate on the
need for EPA to incorporate stopping rules into the IRIS process,
and how would a lack of stopping rules impact the IRIS process?
Ms. STEINZOR. So a stopping rule would be, we are going to look
at this information that is available as of this point. We are going
to apply a weight of the evidence analysis to it. We are going to
write an IRIS profile, and then we are going to put the profile out.
And if there are subsequent studies, we will take a look at those,
and revise the profile as appropriate, on a cycle of five years, as
an example, which is what applies to national ambient air quality
standards, and it has worked fairly well.
Mr. SWALWELL. Thank you. Go Terps, and I yield back the balance of my time.
Ms. STEINZOR. Fear the Turtle.
Dr. OLDEN. May I add to that? We have, in fact, developed firm
stopping rules in our enhancements that we rolled out about last
summer, in July. There are firm stopping rules today.
Thank you.
Chairman BROUN. Very good. Thank you, Dr. Olden. Ms. Edwards, you are recognized for a very quick three minutes, please,
maam.
Ms. EDWARDS. Thank you very much, Mr. Chairman, and I will
be quick. My question is for Mr. Walls. You represent the American
Chemical Council. Is it true that the council spent about $2.9 million in lobbying expenses over this last year, in 2014?
Mr. WALLS. I would assume that is correct.
Ms. EDWARDS. And then in 2013 you spent about $13 million in
lobbying expenses?
Mr. WALLS. I dont have those figures in front of me, but we do
make lobbying expenditures, yes, maam.
Ms. EDWARDS. And I just want to be clear. So my understanding
is that the council has opposed the assessment for formaldehyde,
opposed the assessment coming forward for arsenic, opposed the assessment coming forward for trichloroethylene, TCE, that is
present in our drinking water. Is there an assessment that you all
support the EPA moving forward on?
Mr. WALLS. Congresswoman, our interest is ensure that the best,
highest quality, most reliable science is brought forward to make
those decisions.

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Ms. EDWARDS. Right. What is the
Mr. WALLS. The regulatory
Ms. EDWARDS. last assessment that youwhat is the last assessment that you supported the EPA moving forward on?
Mr. WALLS. We
Ms. EDWARDS. Give me one.
Mr. WALLS. We givewe support a number of assessments.
There isEPA, for example, has a work plan chemical assessment
program in the Office of Pollution Prevention and Toxics, and we
have been clear that we support the agencys moving forward.
Ms. EDWARDS. Have you supported the agency moving forward
on the arsenic assessment?
Mr. WALLS. Congresswoman, we have made clear that our interest is in
Ms. EDWARDS. Have you supported the EPA moving forward
Mr. WALLS. To date
Ms. EDWARDS. on the arsenic assessment?
Mr. WALLS. We support moving forward on assessments in a way
that is
Ms. EDWARDS. Have you supported the EPA moving forward on
the arsenic assessment?
Mr. WALLS. I
Ms. EDWARDS. Have you supported the EPA moving forward on
the formaldehyde assessment?
Mr. WALLS. We have supported the agency moving forward on
IRIS assessments, but to do so in a manner that
Ms. EDWARDS. Have youI just want a yes or no, if you could.
Have you supported the
Mr. WALLS. I cant
Ms. EDWARDS. EPA moving
Mr. WALLS. I cant
Ms. EDWARDS. forward on the
Mr. WALLS. a yes or no
Ms. EDWARDS. formaldehyde assessment?
Mr. WALLS. Congresswoman.
Ms. EDWARDS. No?
Mr. WALLS. We have supported moving forward on the assessment in a way
Ms. EDWARDS. On the formaldehyde assessment?
Mr. WALLS. In a way that
Ms. EDWARDS. Support
Mr. WALLS. reflects the
Ms. EDWARDS. the EPA
Mr. WALLS. recommendations made
Ms. EDWARDS. moving forward on the
Mr. WALLS. by the
Ms. EDWARDS. formaldehyde assessment? Did youdid the
American Chemistry Council have anything at all to do, or spend
any lobbying expenses, on ensuring that the EPA could not move
forward, and this Congress could not move forward, on the arsenic
assessment? Did you all lobby on that issue at all
Mr. WALLS. I
Ms. EDWARDS. in the Congress?

93
Mr. WALLS. I dont have direct knowledge of that, but I assume
we did, yes.
Ms. EDWARDS. I will be following up with additional questions.
Mr. WALLS. I will look forward
Ms. EDWARDS. Thank you very
Mr. WALLS. to your questions.
Ms. EDWARDS. much to the witnesses.
Chairman BROUN. Thank you, Ms. Edwards. Apologize for the
fast round of questions. We have two more minutes in this vote,
so we are going to submit questions for the record, and you can answer them. You can put a lot more flesh on these. Thank you for
your flexibility. And, again, I apologize for the hasty period of time.
I thank Members for you alls flexibility. The record will remain
open for two weeks for additional comments and written questions
from Members. The witnesses are now excused. This hearing is adjourned, and thank you all.
[Whereupon, at 2:27 p.m., the Subcommittees were adjourned.]

Appendix I

ANSWERS

TO

POST-HEARING QUESTIONS

(95)

96
ANSWERS
Responses by Dr. David Dorman

TO

POST-HEARING QUESTIONS

97

98

99

100
Responses by Dr. Dr. Kenneth Olden

101

102

103

104

105

106

107

108

109

110

111

112

113

114
Responses by Dr. Ms. Rena Steinzor

115

116

117

118

119

120

121

122

123
Responses by Dr. Mr. Michael P. Walls

124

125

126

Appendix II

ADDITIONAL MATERIAL

(127)

FOR THE

RECORD

128
PREPARED STATEMENT OF FULL COMMITTEEE RANKING MEMBER
EDDIE BERNICE JOHNSON
Thank you Mr. Chairman. Virtually every aspect of our daily lives is impacted by
the use and presence of chemicals. The goal of the Integrated Risk Information System (IRIS) at EPA is to provide information to the American people about the risks
associated with exposure to certain chemicals. It should be obvious to anyone that
information about the health effects of chemical exposures can only benefit the public. Unfortunately, the value of IRIS is too often obscured by the criticisms of those
who stand to gain by interfering with EPAs mission to protect human health and
the environment.
The National Academies report released this May praises the substantial improvement made by EPA in addressing issues that had been raised about the IRIS process. Specifically, the report states that if EPA continues on this path of improvement, the IRIS process will become much more effective and efficient in achieving
its basic goal of developing human-health assessments that can provide the scientific foundation for ensuring that risks posed to public health by chemicals are
assessed and managed properly. The report also points out two important future
steps which EPA can take to further improve the quality of their IRIS assessments.
First, EPA must continue to expand opportunities for stakeholder input and discussion. The chemical industry is not the only stakeholder in public health assessments. Community groups and public health organizations do not always have the
same resources to support meaningful participation in the public processes of IRIS.
The EPA must not permit a privileged few to monopolize a process meant to foster
open discussion.
Second, EPA should be diligent in developing firm stopping rules, that guard
against undue delay in releasing its assessments. Hundreds of new chemicals are
released onto the market every year with no requirement that their safety be demonstrated. IRIS was created to address this lack of information on the potential toxicity of these chemicals and their influence on human health.
Unfortunately, the pace at which IRIS finalizes its assessments has slowed to an
unacceptable rate. It is time EPA moves ahead with urgency to bridge this gap and
fulfill its mission. I am looking forward to hearing from Dr. Olden on this matter.
It is clear that IRIS provides a valuable service to the American people. We must
encourage EPA to be diligent in its efforts for continued improvement, and support
them as they implement the recommendations of the National Academies.
Thank you, and I yield back.